The European Medicines Agency said the EU’s Clinical Trials Information System (CTIS) would need extensive rebuilding to accommodate the proposed EU Biotech Act. EMA cited that proposed changes to trial authorization and supervision could affect roughly 70% of current CTIS functionality, with goals including faster assessment timelines and more flexibility for modifying ongoing studies. EMA also indicated that new platform development should start in early 2027, with a detailed redevelopment plan slated for presentation to its management board in December. If the legislative proposals move forward, the first changes to the clinical trials regulatory framework could come into force in early 2028. For biotech sponsors, the CTIS modernization signal means planning for operational migrations and process adjustments—particularly around cross-member state collaboration and accelerated assessment mechanics.